EP0450098B1 - Herstellungsverfahren für gummistöpsel von medizinfläschchen - Google Patents

Herstellungsverfahren für gummistöpsel von medizinfläschchen Download PDF

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Publication number
EP0450098B1
EP0450098B1 EP90915188A EP90915188A EP0450098B1 EP 0450098 B1 EP0450098 B1 EP 0450098B1 EP 90915188 A EP90915188 A EP 90915188A EP 90915188 A EP90915188 A EP 90915188A EP 0450098 B1 EP0450098 B1 EP 0450098B1
Authority
EP
European Patent Office
Prior art keywords
rubber
synthetic resin
resin film
vial
sheet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP90915188A
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English (en)
French (fr)
Other versions
EP0450098A1 (de
EP0450098A4 (en
Inventor
Masaru Matsuzaki
Yoshihide Aoki
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nissho Corp
Original Assignee
Nissho Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nissho Corp filed Critical Nissho Corp
Publication of EP0450098A1 publication Critical patent/EP0450098A1/de
Publication of EP0450098A4 publication Critical patent/EP0450098A4/en
Application granted granted Critical
Publication of EP0450098B1 publication Critical patent/EP0450098B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B29C43/14—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles in several steps
    • B29C43/146—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles in several steps for making multilayered articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B29C43/18—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles
    • B29C43/183—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles the preformed layer being a lining, e.g. shaped in the mould before compression moulding, or a preformed shell adapted to the shape of the mould
    • B29C43/184—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles the preformed layer being a lining, e.g. shaped in the mould before compression moulding, or a preformed shell adapted to the shape of the mould shaped by the compression of the material during moulding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B29C43/20—Making multilayered or multicoloured articles
    • B29C43/203—Making multilayered articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C70/00—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts
    • B29C70/68—Shaping composites, i.e. plastics material comprising reinforcements, fillers or preformed parts, e.g. inserts by incorporating or moulding on preformed parts, e.g. inserts or layers, e.g. foam blocks
    • B29C70/78—Moulding material on one side only of the preformed part
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2791/00—Shaping characteristics in general
    • B29C2791/001—Shaping in several steps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C2793/00—Shaping techniques involving a cutting or machining operation
    • B29C2793/009—Shaping techniques involving a cutting or machining operation after shaping
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2021/00—Use of unspecified rubbers as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/56—Stoppers or lids for bottles, jars, or the like, e.g. closures
    • B29L2031/565—Stoppers or lids for bottles, jars, or the like, e.g. closures for containers

Definitions

  • the present invention relates to a method for producing a rubber stopper for a vial, and more particularly to a method for producing a rubber stopper for a vessel for medicine, which is covered with a synthetic resin film.
  • a rubber stopper of which surface being contacted with a liquid medicine is laminated with a synthetic resin film having a chemical resistance has conventionally been sometimes used as disclosed in Japanese Examined Patent Publication No. 9119/1979, Japanese Unexamined Patent Publication No. 47637/1982 and so on.
  • the precharacterizing part of claim 1 refers to a method for producing a rubber stopper as disclosed in US-A-4 397 903.
  • the document is directed to an apparatus and a method for producing a rubber stopper having a plug portion and a head portion.
  • the axial end face of the plug portion is provided with a facing or liner made of chemically inert material.
  • the known method broadly consists of laminating a thin sheet of elastomeric material such as uncured rubber, to one face of a thin sheet of inert material being chemically etched to produce a static cling to securely adhere the sheets together.
  • the laminated sheet is cut into a plurality of circular discs of a predetermined size to form the liner facing in the finished article.
  • the discs are then forced into mould cavities for the article to be manufactured. Thereafter, additional elastomeric material is placed into a mould and moulded in a conventional manner. Since the laminated sheet has to be cut into a plurality of circular discs which have to be inserted into a mould, the process for producing a covered rubber stopper is complicated as a whole.
  • fluorocarbon resin nylon, polyethylene, polypropylene and the like are given, and these materials are suitably selected in accordance with chemicals which are contained in a vial. It is necessary that these films have an adhesion property to the rubber based upon the vulcanization. As occasion demands, in order to improve the adhesive property, a treatment such as a chemical treatment, a corona discharge treatment or a sputter-etching treatment can be carried out.
  • a synthetic rubber such as butyl rubber, halogenated butyl rubber, butadiene rubber, isoprene rubber, ethylene-propylene rubber or silicone rubber or natural rubber is used.
  • a compounding ingredient for a rubber is usually contained in the material of the rubber.
  • a half-vulcanized rubber sheet In the step for producing a secondary formed article, a half-vulcanized rubber sheet finally prevents the synthetic resin sheet from peeling off, and plays a part in sealing or packing when the rubber stopper is used in the vial 13 as shown by a phantom line in Fig. 3.
  • the reason why not an unvulcanized rubber but a half-vulcanized rubber is used in such a rubber sheet is that flowing into the portion of the synthetic resin film is avoided during vulcanization and thereby the surface of the film is prevented from pollution.
  • the degree of vulcanization for the half-vulcanized rubber is suitably decided by the components of the rubber, temperature for vulcanizing in a secondary forming step and the like.
  • the reason for pressing and heating in this step is to obtain a rigid completed secondary formed article by covering and bonding the lower face of the head portion or the whole surface except the plug or leg portion with a rubber layer and completing the vulcanization of the whole rubber.
  • the step for cutting down a flash from a secondary formed article is generally employed in case of manufacturing rubber products from a sheet-like rubber material.
  • a first mold B which is a lower side mold of a set of molds for the primary forming has a cavity 5 somewhat deeper than a real size of the leg portion (4 in Fig. 3) of the final product, and an upper side second mold A has a cavity 7 which is somewhat shallower than a real size of the head portion (6 in Fig. 3) of the final product
  • Each cavity 5, 7 is provided with a projection 5a, 7a corresponding to the respective recess (4a, 6a in Fig. 1b) to be formed at the center of a product in order to improve forming accuracy.
  • a laminate of a synthetic resin film 1 and an unvulcanized rubber sheet 2 is put between the molds A and B, and forming, vulcanizing and adhesion by crosslinking are carried out by pressing and heating.
  • primary formed articles 8 which are still linked with each other through a sheet-like flash which is formed by melting the periphery part of a product once and then re-forming it.
  • the primary formed article has a body of the rubber stopper covered with a synthetic resin material at the lower side (at the leg side) thereof.
  • the conditions of pressing and heating during the primary forming step are changed in accordance with the kind of the used synthetic resin film and rubber, the kind of compounding ingredients, thickness thereof, size of molds and the like, the conditions are usually 130° to 180°C, 50 to 300 kg/cm2 and 5 to 15 minutes.
  • the conditions for vulcanization are adjusted so that the hardness of the primary formed article is lower than the hardness of the final product since vulcanization also proceeds when the primary formed article is re-heated in the secondary forming step.
  • the primary formed article can be formed by pre-vulcanizing only an unvulcanized rubber sheet 2 to an extent, then opening the molds, putting a resin film therebetween, and pressing and heating again to continue the vulcanization.
  • the under face of the head portion 6 is covered with a half-vulcanized rubber sheet 3 having holes 10 of which diameter is almost the same as that of the root portion 9 of the leg portion 4, of the rubber stopper, which is separately produced.
  • the material is pressed and heated between the second molds C and D having shapes adapted to the shape of the final product, and subsequently the body and the half-vulcanized rubber sheet are vulcanized to give a secondary formed article having a forms shown in Fig. 2b.
  • a sheet of 0.5 to 2 mm in thickness can be employed which is produced by vulcanizing a rubber material composed of the same components as the primary product or a rubber material composed of such components that gives a vulcanizing rate slightly higher than the primary formed article at 130° to 180°C for 0.5 to 5 minutes.
  • the obtained secondary formed articles 11 are take out from the molds C, D, and the final products are struck off in order to remove a sheet-like flash. Thereby, such products, as shown in Fig. 3 are obtained.
  • each of the secondary formed articles can be formed by abutting the molds C and D each other, and finally cutting and removing a flash around the rubber stopper.
  • the process is simple since it is not necessary to put each of the leg-shaped-film products or leg portions laminated with a film into the molds one by one, which has been employed in conventional proposed methods. Also, since both a primary formed article and a half- vulcanized sheet with holes have a sheet-like form, those can be easily treated in the process for manufacturing. For example, when a set of molds with multiple cavities is used, a lot of covered rubber stoppers can be manufactured at a time. Accordingly, the covered rubber stoppers can be efficiently and economically mass- produced.
  • the producing method of the present invention is indeed effective for mass-production by multiple cavities, but it can be also employed in such a case that the rubber stoppers are produced one by one.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Casting Or Compression Moulding Of Plastics Or The Like (AREA)
  • Closures For Containers (AREA)

Claims (2)

  1. Verfahren für die Herstellung eines Gummistöpsels für ein Medizinfläschchen (13) mit einem der Öffnung des Medizinfläschchens entsprechenden Schaftteil (4), und mit einem Kopfteil (6), welcher die axiale Endfläche des Medizinfläschchens überlappt, wobei bei diesem Verfahren eine gegen Medikamente oder medizinische Chemikalien resistente synthetische Harzfolie (1) auf eine nicht vulkanisierte Gummifolie (2) aufgesetzt wird,
    dadurch gekennzeichnet, daß
    ein erster Formschritt für die Herstellung eines primären geformten Gegenstandes (8) durchgeführt wird, bei dem die synthetische Harzfolie (1) und die nicht vulkanisierte Gummifolie (2) in Kokillen (A, B) verpreßt und erwärmt werden, wobei die erste Kokille (B) einen Hohlraum (5) aufweist, welcher der Form des Schaftteils (4) des Gummistöpsels entspricht, und die zweite Kokille (A) mit einem Hohlraum (7) versehen ist, welcher der Form des Kopfteils (6) des Gummistöpsels entspricht, und anschließend ein zweiter Formschritt durchgeführt wird, um einen sekundären geformten Gegenstand dadurch herzustellen, daß der primäre geformte Gegenstand (8) an der Unterseite des Gummistöpsels mit einer halb vulkanisierten Gummifolie (3) überzogen wird, wobei diese halb vulkanisierte Gummifolie eine Öffnung (10) aufweist, deren Durchmesser dem Durchmesser des Schaftteils (4) des Gummistöpsels entspricht, und dadurch, daß dieses Produkt in einem Paar Kokillen (C, D) verpreßt und erwärmt wird, welche der Form des Endproduktes entsprechen, um so diesen sekundären geformten Gegenstand zu erhalten, dessen Unterseite mit Ausnahme des Schaftteils (4) mit der Gummischicht überzogen ist, und dadurch, daß ein Folienüberstand von dem sekundären geformten Gegenstand abgeschnitten und entfernt wird.
  2. Verfahren nach Anspruch 1,
    dadurch gekennzeichnet, daß
    nur die in dem primären Formprozeß verwendete nicht vulkanisierte Gummifolie (2) vorher vorvulkanisiert wird und anschließend die Kokillen (A, B) geöffnet werden und die synthetische Harzfolie (1) in die Kokille eingelegt und danach noch ein Mal verpreßt und vulkanisiert wird.
EP90915188A 1989-10-23 1990-10-20 Herstellungsverfahren für gummistöpsel von medizinfläschchen Expired - Lifetime EP0450098B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP275580/89 1989-10-23
JP1275580A JPH0620764B2 (ja) 1989-10-23 1989-10-23 バイアル用ゴム栓の製造方法
PCT/JP1990/001359 WO1991005649A1 (fr) 1989-10-23 1990-10-20 Procede de production de bouchons en caoutchouc pour fioles

Publications (3)

Publication Number Publication Date
EP0450098A1 EP0450098A1 (de) 1991-10-09
EP0450098A4 EP0450098A4 (en) 1992-04-01
EP0450098B1 true EP0450098B1 (de) 1995-09-13

Family

ID=17557438

Family Applications (1)

Application Number Title Priority Date Filing Date
EP90915188A Expired - Lifetime EP0450098B1 (de) 1989-10-23 1990-10-20 Herstellungsverfahren für gummistöpsel von medizinfläschchen

Country Status (6)

Country Link
US (1) US5217668A (de)
EP (1) EP0450098B1 (de)
JP (1) JPH0620764B2 (de)
KR (1) KR0137365B1 (de)
DE (1) DE69022398T2 (de)
WO (1) WO1991005649A1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102123691A (zh) * 2008-08-29 2011-07-13 美国圣戈班性能塑料公司 密封组件以及制造此种组件的方法

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH07115370B2 (ja) * 1993-10-06 1995-12-13 有限会社上総硬質クローム ゴム成形品の製造方法及び製造装置
JPH07172449A (ja) * 1993-12-21 1995-07-11 Kazusa Koushitsu Kuroomu:Kk ゴム栓
JP2876310B2 (ja) * 1996-11-28 1999-03-31 株式会社上総硬質クローム 擦傷を防止したゴム栓
JP3512349B2 (ja) * 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
JP2002086481A (ja) * 2000-09-14 2002-03-26 Terumo Corp ガスケットの製造方法
JP2003190282A (ja) 2001-12-27 2003-07-08 Terumo Corp 金属製の管状体およびその製造方法
JP2004216753A (ja) * 2003-01-16 2004-08-05 Sumitomo Rubber Ind Ltd 医薬用ゴム栓の製造方法
CA2717894C (en) 2008-03-05 2014-05-27 Becton, Dickinson And Company Capillary action collection device and container assembly
CA2718060C (en) * 2008-03-05 2015-08-04 Becton, Dickinson & Company Co-molded pierceable stopper and method for making same
EP2250992A1 (de) * 2009-05-13 2010-11-17 Hubei Huaqiang High-Tech Co., Ltd. Teilweise mit PET-Folie beschichteter Gummistopfen und dessen Herstellungsverfahren
US8460620B2 (en) 2010-12-03 2013-06-11 Becton, Dickinson And Company Specimen collection container assembly
JP6243096B2 (ja) * 2011-11-16 2017-12-06 株式会社大協精工 バイアル用ゴム栓
JP6403258B2 (ja) * 2014-09-16 2018-10-10 住友ゴム工業株式会社 医療用ゴム栓の製造方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS549119A (en) * 1977-06-23 1979-01-23 Kawasaki Steel Co Cooling method of cast strips in continuous casting
US4397903A (en) * 1979-01-18 1983-08-09 The West Company Molded articles
FR2487566A1 (fr) * 1980-07-25 1982-01-29 Thomson Csf Matrice de detection d'un rayonnement electromagnetique et intensificateur d'images radiologiques comportant une telle matrice
JPS5844070B2 (ja) * 1980-09-03 1983-09-30 富士化学紙工業株式会社 インク保持多孔体の製造法
JPS5747637A (en) * 1980-09-06 1982-03-18 Daikyo Gomme Seikou:Kk Manufacture of laminate rubber stopper
EP0204486B1 (de) * 1985-05-28 1990-10-17 Daikyo Gomu Seiko Ltd. Harzlaminierter Kunststoffstopfen und dessen Herstellung
JPS62176450A (ja) * 1986-08-27 1987-08-03 株式会社大協精工 医薬用積層ゴム栓

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102123691A (zh) * 2008-08-29 2011-07-13 美国圣戈班性能塑料公司 密封组件以及制造此种组件的方法
CN102123691B (zh) * 2008-08-29 2014-07-16 美国圣戈班性能塑料公司 密封组件以及制造此种组件的方法

Also Published As

Publication number Publication date
EP0450098A1 (de) 1991-10-09
JPH0620764B2 (ja) 1994-03-23
DE69022398T2 (de) 1996-03-07
DE69022398D1 (de) 1995-10-19
US5217668A (en) 1993-06-08
JPH03136820A (ja) 1991-06-11
KR0137365B1 (en) 1998-04-25
EP0450098A4 (en) 1992-04-01
WO1991005649A1 (fr) 1991-05-02

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